Real-world experience of children with growth hormone deficiency who switched from daily growth hormone to the Long-Acting Growth Hormone Somatrogon

Study type

• Study topic:
  Disease /health condition

  Human medicinal product

  Other
• Study topic, other:
  Paediatric growth disorders/Growth Hormone Deficiency treatment in children
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  GENOTROPIN

  NGENLA
• Study drug International non-proprietary name (INN) or common name:
  SOMATROGON

  SOMATROPIN
• Anatomical Therapeutic Chemical (ATC) code:
  (H01AC08) somatrogon

  somatrogon

  (H01AC01) somatropin

  somatropin
• Medical condition to be studied:
  Growth hormone deficiency

Population studied

• Short description of the study population:
  The target population consists of patients who transitioned from daily GH therapy to weekly somatrogon, a long-acting hGH treatment, as prescribed by their treating physician in routine clinical practice. The source population includes patients from the Maccabi HCO database in Israel and the REPAR registry in the Czech Republic. Eligible patients are male or female, up to 17 years old at the start of the pre-index period, with at least 6 months of data on daily GH treatment (somatropin) and a minimum of 6 months of follow-up data after switching to long-acting somatrogon.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  450

Study design details

• Study design:
  This is a multi-country, non-interventional, retrospective cohort study, utilizing structured data of patients up to 17 years old who switched from daily GH to weekly somatrogon, a long-acting hGH treatment, as prescribed by the treating physician according to routine clinical care
• Main study objective:
  Primary Objective: ; • To evaluate and compare the growth hormone treatment effectiveness in participants who switched from daily growth hormone to weekly somatrogon. ; Secondary Objectives: ; • To evaluate and compare the safety profile of weekly somatrogon and daily somatropin in children with GHD ; • To assess the proportion of patients that switched back to daily somatropin among ; patients receiving somatrogon ; 090177e1a63e9414\Approved\Approved On: 09-Jun-2026 12:02 (GMT); • To assess reasons for switch-back among patients who switched back from somatrogon to daily GH ; • To evaluate and compare adherence to growth hormone treatment of participants before and after switching to somatrogon treatment.
• Setting:
  The source populations are patients included in the Maccabi HCO database in Israel and the REPAR database in the Czech Republic.
• Comparators:
  daily somatropin
• Outcomes:
  Outcomes: The outcomes for the primary objective are Height, Height SDS, annual Height velocity, and annual Height velocity SDS. The secondary objective outcomes of interest are weight, weight SDS, difference in weight SDS, Body mass index (BMI), BMI SDS, difference in BMI, difference in BMI SDS, bone age and difference in bone age, injection site reactions, treatment adherence and compliance, proportion of patients that switched back and ; reason for switch back to daily GH.